QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
FDA 510(k) clearance DEN130005 · decided 2013-08-08
Clearance details
- K-number
- DEN130005
- Device name
- QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Unknown
- Date received
- 2013-05-28
- Decision date
- 2013-08-08
- Days to decision
- 72 days
- Clearance type
- Post-NSE
- Product code
- PDY
- Device class
- 2
- Regulation number
- 862.3652
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |